This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Fluency Plus Endovascular Stent Graft
PMA Applicant: Bard Peripheral Vascular, Inc.
Address: 1625 West 3rd Street, P.O. Box 1740, Tempe, AZ 85280-1740
Approval Date: June 17, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130029a.pdf
What is it? The Fluency Plus Endovascular Stent Graft opens up a new blockage in a previously placed stent on the venous side of the dialysis access circuit. The stent graft is placed inside the stent to re-open it allowing adequate blood to flow and dialysis to take place.
The stent graft is a self-expandable, flexible, metal (Nitinol) tube-shaped stent lined with a plastic graft made from expanded polytetrafluoroethylene (ePTFE).
The stent graft is located on the end of a delivery catheter; a long, thin, tube-like device and is held in place by a release mechanism and outer tube (sheath).
How does it work?
- A catheter with a deflated balloon at its tip is inserted into a blood vessel. The catheter is advanced through blood vessels to the venous side of the dialysis access circuit where the blockage (stent lesion) is located that is disrupting blood flow.
- The balloon is inflated within the narrowed stent lesion to open it (balloon angioplasty).
- The balloon and its catheter are removed.
- The delivery catheter with the attached stent graft is advanced through the same blood vessels and positioned within the stent.
- The stent graft is then released (deployed) by pulling back (retracting) the sheath after it is positioned and opens automatically so that it is pressing against the stent in the venous outflow tract that returns the dialyzed blood.
- Once the stent graft is deployed, the delivery catheter is removed.
- The stent graft increases blood flow by holding the blood vessel wall open.
- The stent graft remains permanently implanted in the blood vessel and acts as a support for the re-opened section of the blood vessel.
When is it used? The Fluency Plus Endovascular Stent Graft is used to treat in-stent re-narrowing (restenosis) or a blockage that has developed inside an already placed stent in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (AV) fistula or AV access graft.
An AV fistula is a direct connection between an artery and vein while an AV access graft acts as an artificial blood vessel that goes between an artery and a vein. The AV access graft can be used repeatedly to draw blood with a needle during hemodialysis.
What will it accomplish? Use of the Fluency Plus Endovascular Stent Graft will restore blood flow to the venous outflow of an AV fistula or AV access graft and keep the area open longer compared to treatment with balloon angioplasty alone.
When should it not be used? There are no known contraindications.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.